A Phase 2 Study to Investigate Efficacy and Safety of HZN-1116 in Participants With Sjogren's Syndrome

NCT06312020 | Terminated Phase 2 FDA Drug

• 1 other identifier: HZNP-HZN-1116-201
• Study Type: interventional
• Target: 209
• Locations: 16 countries
• Sites: 66

Brief Summary

The purpose of this study is to measure the efficacy and safety of HZN-1116 in participants with Sjogren's syndrome (SS).

Conditions

Sjogren's Syndrome

Keywords

SS; Sjogren's; HZN-1116; Autoimmune disease; Dry Eye syndrome; VIB1116

Outcome Measures

Primary Outcomes (2)

• Change from baseline in European Alliance of Associations for Rheumatology (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) (Population #1)

  At Week 48

• Change from baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) (Population #2)

  At Week 24

Secondary Outcomes (23)

• Change from baseline in ESSDAI (Population #1)

  At Week 24

• Proportion of Participants achieving ESSDAI [5] response (Population #1)

  At Week 24 and Week 48

• Change from baseline in ESSPRI pain domain score (Population #1)

  At Week 24 and Week 48

• Change from baseline in Diary for Assessing Sjogren's Patient-Reported Outcome Index (DASPRI) pain domain score (Population #1)

  At Week 24 and Week 48

• Change from baseline in ESSPRI fatigue domain score (Population #1)

  At Week 24 and Week 48

Study Arms (8)

HZN-1116 Dose 1 in Population 1

EXPERIMENTAL

Participants will receive Dose 1 of HZN-1116

Drug: HZN-1116

HZN-1116 Dose 2 in Population 1

EXPERIMENTAL

Participants will receive Dose 2 of HZN-1116

Drug: HZN-1116

Placebo in Population 1

PLACEBO COMPARATOR

Participants will receive Placebo matched to HZN-1116

Drug: Placebo

HZN-1116 Dose 1 in Population 2

EXPERIMENTAL

Participants will receive Dose 1 of HZN-1116

Drug: HZN-1116

HZN-1116 Dose 2 in Population 2

EXPERIMENTAL

Participants will receive Dose 2 of HZN-1116

Drug: HZN-1116

HZN-1116 Dose 3 in Population 2

EXPERIMENTAL

Participants will receive Dose 3 of HZN-1116

Drug: HZN-1116

HZN-1116 Dose 4 in Population 2

EXPERIMENTAL

Participants will receive Dose 4 of HZN-1116

Drug: HZN-1116

Placebo in Population 2

PLACEBO COMPARATOR

Participants will receive Placebo matched to HZN-1116

Drug: Placebo

Interventions

HZN-1116 DRUG

Subcutaneous Administration

Also known as: VIB1116, AMG 329

HZN-1116 Dose 1 in Population 1; HZN-1116 Dose 1 in Population 2; HZN-1116 Dose 2 in Population 1; HZN-1116 Dose 2 in Population 2; HZN-1116 Dose 3 in Population 2; HZN-1116 Dose 4 in Population 2

Placebo DRUG

Subcutaneous Administration

Placebo in Population 1; Placebo in Population 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
• Have an ESSDAI score of \>= 5 at screening (only for Population 1).
• Have an ESSPRI score of \>= 5 at screening (only for Population 2).
• Have an ESSDAI score of \< 5 at screening (only for Population 2).
• Positive for anti-Ro autoantibodies, rheumatoid factor (RF) at screening, or both at screening.

You may not qualify if:

• Concomitant system sclerosis.
• Active malignancy or history of malignancy within the last 5 years with exception of in situ carcinoma of the cervix treated with apparent success with curative therapy \> 12 months prior to screening; OR cutaneous basal cell carcinoma following presumed curative therapy.
• Individuals who are pregnant or lactating or planning to become pregnant during the study.
• Individuals who have a positive test for, or have been treated for, hepatitis B, hepatitis C, or HIV infection.
• Individuals with history of more than one episode of herpes zoster and/or opportunistic infections in the last 12 months, with the exception of non-invasive herpes simplex at any site, oral candidiasis, vaginal candidiasis, or cutaneous fungal infections, which are permitted within the prior 12 months unless of unusual severity. Individuals with a prior history of ophthalmic herpes zoster will be excluded.
• Active infections requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
• Last administration of experimental biologic or oral agents \< 6 months or 5 half-lives, whichever is longer, before screening.
• Individuals who have had previous treatment with any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, or ofatumumab) within 12 months or other B cell targeting therapy (eg, belimumab) or anti-type I IFN pathway therapy (eg, anifrolumab) \< 6 months before randomization.

Sponsors & Collaborators

• Amgen: lead

Study Sites (66)

Arizona Arthritis & Rheumatology Research-S Vineyard Ave

Mesa, Arizona, 85210-6871, United States

Location

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, 85032-9306, United States

Location

Neurovations Research

Napa, California, 94558-2415, United States

Location

Life Arc Research Centers Corp

Miami, Florida, 33126, United States

Location

IRIS Research and Development LLC

Plantation, Florida, 33324-2736, United States

Location

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606-1246, United States

Location

Augusta University Medical Center-Augusta-1120 15th St

Augusta, Georgia, 30912-0004, United States

Location

Tufts Medical Center - 800 Washington St - PPDS

Boston, Massachusetts, 02111-1552, United States

Location

Pioneer Clinical Research NY

New York, New York, 10016-7313, United States

Location

DJL Clinical Research PLLC-431 N Wendover Rd

Charlotte, North Carolina, 28211-1064, United States

Location

Altoona Center for Clinical Research - 175 Meadowbrook Ln

Duncansville, Pennsylvania, 16635-8445, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305-2883, United States

Location

Tekton Research, LLC - W Gate Blvd - Austin - PPDS

Austin, Texas, 78745, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054-2853, United States

Location

R & H Clinical Research - Katy - 1531 Westborough Dr

Katy, Texas, 77449, United States

Location

University Of Wisconsin - Madison

Madison, Wisconsin, 53792-0001, United States

Location

MR Medicina Reumatologica

San Fernando, Buenos Aires, B1646GHP, Argentina

Location

DOM Centro de Reumatología

Buenos Aires, Ciudad Autónoma de BuenosAires, C1107, Argentina

Location

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, C1128AAF, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, Ciudad Autónoma de BuenosAires, C1417, Argentina

Location

Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina

Location

LKH-Universitätsklinikum Graz - Auenbruggerplatz 15

Graz, Styria, 8036, Austria

Location

Centro de especialidades médicas Vanguardia

Temuco, Araucania, 4780000, Chile

Location

Biomedica Research Group

Providencia, Región-MetropolitanadeSantiago, 7500000, Chile

Location

Prosalud y Cia Ltda.

Santiago, Región-MetropolitanadeSantiago, 7510047, Chile

Location

Centro de Investigacion de Enfermedades Respiratorias e inmunologicas

Viña del Mar, Valparaiso, 2531172, Chile

Location

Centro Integral de Reumatologia del Caribe S.A.S - CIRCARIBE S.A.S.

Barranquilla, Atlántico, 080001, Colombia

Location

Healthy Medical Center S.A.S.

Zipaquirá, Cundinamarca, 250252, Colombia

Location

Servimed S.A.S

Bucaramanga, 680003, Colombia

Location

AES - AS - Fundacion Centro de Investigacion Clinica - CIC

Medellín, 050021, Colombia

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, Hérault, 34295, France

Location

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200, France

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Mvz Rheumatologie Und Autoimmunmedizin Hamburg Gmbh

Hamburg, 20095, Germany

Location

Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet - Albert Flórián út 5-7

Budapest, 1097, Hungary

Location

Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

Rome, Lazio, 00168, Italy

Location

IRCCS Ospedale Galeazzi - Sant'Ambrogio

Milan, Lombardy, 20157, Italy

Location

PanAmerican Clinical Research - Domingo Sarmiento 2784 - PPDS

Guadalajara, Jalisco, 44670, Mexico

Location

Clinstile, S.A. de C.V.

Mexico City, C.P. 06700, Mexico

Location

Pratia Poznan - PPDS

Poznan, Greater Poland Voivodeship, 60-192, Poland

Location

Prywatna Praktyka Lekarska Pawel Hrycaj

Poznan, Greater Poland Voivodeship, 61-397, Poland

Location

Centrum Medyczne PROMED

Krakow, Lesser Poland Voivodeship, 31-513, Poland

Location

MICS Centrum Medyczne Warszawa, Wronia - MICS

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. El. Reicher- Spartanska 1

Warsaw, Masovian Voivodeship, 02-637, Poland

Location

Klinika Reuma Park sp . zoo Sp.k.

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Masovian Voivodeship, 02-672, Poland

Location

FutureMeds - Targowek - PPDS

Warsaw, Masovian Voivodeship, 03-291, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Sp. Z o.o.

Malbork, Pomeranian Voivodeship, 82-200, Poland

Location

FutureMeds - Krakow - PPDS

Krakow, 31-501, Poland

Location

ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS

Lisbon, 1649-035, Portugal

Location

Hospital Conde de Bertiandos - Unidade Local de saúde do Alto Minho, EPE - Ponte de Lima

Ponte de Lima, 4990-041, Portugal

Location

ULS de Santo António, EPE - Hospital de Santo António

Porto, 4099-001, Portugal

Location

Hospital Sanitas CIMA

Barcelona, 08034, Spain

Location

Hospital General Universitario de Castellon

Castellon, 12004, Spain

Location

Hospital Universitario Virgen de Las Nieves

Granada, 18014, Spain

Location

Clinicas Gaias-Santiago

Santiago de Compostela, 15702, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Quironsalud Sagrado Corazon

Seville, 41013, Spain

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Medical University Hospital - PPDS

Taipei, 11031, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan City, 33305, Taiwan

Location

Basingstoke and North Hampshire Hospital

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Sjogren's Syndrome; Autoimmune Diseases; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 15, 2024
• Study Start: May 9, 2024
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CH (1); CL (4); PT (3); PL (10); GB (1); TW (5); AR (5); CO (4); FR (2); AU (1); ES (6); HU (2); US (16); IT (2); DE (2); ME (2)